NATCO Pharma receives 7 observations from USFDA

20 Jun 2025 , 12:25 PM

NATCO Pharma Limited announced that United States Food and Drug Administration (USFDA) has completed inspection at its pharmaceutical manufacturing facility located in Kothur, Hyderabad. The company was under inspection for a period of 10 days between June 9-19, 2025. After completion, the company has received seven observations in Form 483 from the FDA.

In a statement, NATCO Pharma stated it is confident of addressing all the observations within the stated time frame. The company added that it is committed to current Good Manufacturing Practices (cGMP) compliance and to deliver high-quality products to its international customer and patient base.

The business posted a consolidated net profit of ₹406 Crore in the quarter ended March 2025. This was a 5% year-on-year increase against ₹386.30 Crore in the previous corresponding quarter. 

The business logged revenue from operations of ₹1,287.30 Crore, registering a growth of 16%. In the same quarter of previous year, the business posted revenue of ₹1,110.30 Crore.

The business logged an EBITDA of ₹548 Crore in the quarter ended March 2025, up by 10.20% on a year-on-year basis. EBITDA margin came in at 44.89%, marginally lower than 46.55% in the previous corresponding quarter. 

For feedback and suggestions, write to us at [e-mail]